Overall Comparison of Single Dose 100mg Rectal Diclofenac With Double Doses of 20mg Twelve Hours Apart Oral Diclofenac for Pain Relief Both for 24 Hours After Episiorrhahpy, Southeast Nigeria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Adequate pain relief after drug administration
研究概览
简要总结
Episiotomy is the commonest surgical procedure performed on parturient. It is usually associated with perineal pain which is particularly severe in the first 24 hours post repair. Perineal pain after episiorrhaphy if not adequately managed puts the woman into painful distress thus preventing good immediate post-partum care for the newborn. The aim is to compare the efficacy of single dose rectal diclofenac with oral diclofenac for the relief of perineal pain within 24 hours after episiotomy repair at Alex Ekwueme Federal University Teaching Hospital Abakaliki.
详细描述
Episiotomy is the commonest surgical procedure performed on parturient. It is usually associated with perineal pain which is particularly severe in the first 24 hours post repair. Perineal pain after episiorrhaphy if not adequately managed puts the woman into painful distress thus preventing good immediate post-partum care for the newborn.
Aim: To compare the efficacy of single dose rectal diclofenac with oral diclofenac for the relief of perineal pain within 24 hours after episiotomy repair at Alex Ekwueme Federal University Teaching Hospital Abakaliki.
Materials and Methods
This was a randomized controlled trial that involved 146 women that had episiorrhaphy between June and December 2020. The women were randomized into two groups of 73 women each using computer generated random numbers. One group received 100mg of diclofenac suppository stat while the other group received 2 doses of 50mg of oral diclofenac 12 hours apart, both for 24 hours after episiorrhaphy. Pain was assessed at 1, 4, 8, 16 and 24 hours post episiorraphy using a Visual Analogue Scale. Maternal satisfaction for the mode of the pain relief was assessed using the Likert scale after 24 hours. Data obtained was analyzed using Statistical Package for Social Science software version 25.
The perineal pain was categorized into: no pain (0cm), mild (1-3cm), moderate (4-7cm) and severe (8-10cm), while maternal satisfaction was categorized into: Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied. Categorical variables were summarized using frequencies and proportion. Quantitative variables were summarized with means and standard deviation. Student t-test was used for comparison between the group means for continuous variables while Chi-squared test was used to compare categorical variables. Statistical significance was obtained when p-value was ≤ 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Uncomplicated pregnancy
- •Gestational age of 37 weeks and above who had episiotomy
- •Singleton gestation
- •Vaginal delivery
- •Instrumental vaginal delivery
- •Consented women
排除标准
- •Women that declined consent
- •Postpartum hemorrhage.
- •Women who had perineal tear
- •History of peptic ulcer diseases
- •History of bleeding coagulopathies
- •Adverse reaction or hypersensitivity to diclofenac
- •Any woman with special postpartum pain relief plan such as sickle cell disease patient
- •Preeclamptic/eclamptic, renal and liver diseases patients.
- •Parturient on epidural anesthesia
研究组 & 干预措施
Arm 1, oral diclofenac
Two doses of 50mg oral diclofenac 12 hours apart was administered to this arm
干预措施: Diclofenac (Drug)
Arm 2, rectal diclofenac
100mg diclofenac was administered rectally to this arm
干预措施: Diclofenac (Drug)
结局指标
主要结局
Adequate pain relief after drug administration
时间窗: 24hours
Clients satisfaction
次要结局
未报告次要终点
研究者
Nwali Matthew Igwe
Principal Investigator
Federal Teaching Hospital Abakaliki